Adqc Manager Drug Product

vor 13 Stunden

Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**About Idorsia Pharmaceuticals Ltd**

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for a motivated* ADQC Manager* to join our dynamic team

**Job's Responsibilities**

Analytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines. The Manager working in AD/QC will have the following responsibilities and tasks which are related to the company HQ:

- Manages a team of up to 3 direct reports.
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial).
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOP’s.
- Development, optimization and implementation of analytical methods, e.g., for purity-, stability-,cleaning verification/validation-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
- Representation of AD/QC in technical project team and CMC team meetings
- Conduct of release, retest, stability studies, transfer and validation analyses.
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
- Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
- Write-up and review of analytical protocols and reports and establish specifications.
- Assurance of adequate maintenance and operation of analytical equipment according to GMP.
- Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
- Organization of GMP-(re)qualification and validation of analytical equipment with external companies.
- Elaboration of qualification plans and review of qualification documents.
- Ensuring initial and continuing training of the personnel of AD/QC and adaptation according to business needs
- Ensuring of cleanliness of laboratory and workspace.
- Independently designs and executes projects or experiments with hands on involvement.
- Independently reviews scientific work in project related activities.
- Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Independent evaluation and development of novel analytical techniques and instrumentation.
- Leverages workload of respective project members to assure timelines and budget are met.
- Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with
- Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
- Set and accomplish product development timelines working closely with formulation scientist.
- Responsible for the management of the GMP laboratory and employees
- Responsible for the analytical expertise for defined Idorsia drug substances and/or drug products
- Summarizing, defending and communicating results and product quality issues to management
- Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.
- Participate in technology transfer between laboratories, both internal and external to the company.
- Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures
- College-, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical i

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